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SEROQUEL XL 50MG PROLONGED RELEASE TABLETS

Active substance(s): QUETIAPINE / QUETIAPINE FUMARATE / QUETIAPINE / QUETIAPINE FUMARATE / QUETIAPINE / QUETIAPINE FUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Seroquel® XL 50mg Prolonged Release Tablets /
Seroquel® XL 200mg Prolonged Release Tablets /
Seroquel® XL 300mg Prolonged Release Tablets /
Seroquel® XL 400mg Prolonged Release Tablets
(quetiapine fumarate)
This medicine is available using any of the above names but will be referred to as
Seroquel XL throughout the following patient information leaflet. Please note that the
leaflet also contains information about other strength (Seroquel XL 150mg Prolonged
Release Tablets).
Read all of this leaflet carefully before you start taking this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
 If you get any side effects talk to your doctor or pharmacist. This includes any side
effects not listed in this leaflet. See Section 4.
In this leaflet:
1. What Seroquel XL is and what it is used for
2. What you need to know before you take Seroquel XL
3. How to take Seroquel XL
4. Possible side effects
5. How to store Seroquel XL
6. Contents of the pack and other information
1. What Seroquel XL is and what it is used for
Seroquel XL contains a substance called quetiapine. This belongs to a group of
medicines called anti-psychotics. Seroquel XL can be used to treat several illnesses,
such as:
 Bipolar depression and major depressive episodes in major depressive disorder:
where you feel sad. You may find that you feel depressed, feel guilty, lack energy,
lose your appetite or can’t sleep.
 Mania: where you may feel very excited, elated, agitated, enthusiastic or
hyperactive or have poor judgment including being aggressive or disruptive.
 Schizophrenia: where you may hear or feel things that are not there, believe things
that are not true or feel unusually suspicious, anxious, confused, guilty, tense or
depressed.
When Seroquel XL is being taken to treat major depressive episodes in major
depressive disorder, it will be taken in addition to another drug being used to treat this
illness.
Your doctor may continue to prescribe Seroquel XL even when you are feeling better.
2. What you need to know before you take Seroquel XL
Do not take Seroquel XL:
 If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of
Seroquel XL (see Section 6: Further information)
 If you are taking any of the following medicines:
− some medicines for HIV
− azole medicines (for fungal infections)
− erythromycin or clarithromycin (for infections)
− nefazodone (for depression).
Do not take Seroquel XL if the above applies to you. If you are not sure, talk to your
doctor or pharmacist before taking Seroquel XL.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Seroquel XL if:
 You, or someone in your family, have or have had any heart problems, for example
heart rhythm problems, weakening of the heart muscle or inflammation of the heart
or if you are taking any medicines that may have an impact on the way your heart
beats.
 You have low blood pressure.
 You have had a stroke, especially if you are elderly.
 You have problems with your liver.
 You have ever had a fit (seizure).
 You have diabetes or have a risk of getting diabetes. If you do, your doctor may
check your blood sugar levels while you are taking Seroquel XL.
 You know that you have had low levels of white blood cells in the past (which may
or may not have been caused by other medicines).
 You are an elderly person with dementia (loss of brain function). If you are,
Seroquel XL should not be taken because the group of medicines that Seroquel XL
belongs to may increase the risk of stroke, or in some cases the risk of death, in
elderly people with dementia.
 You or someone else in your family has a history of blood clots, as medicines like
these have been associated with formation of blood clots.
 You have or have had a condition where you stop breathing for short periods
during your normal nightly sleep (called “sleep apnoea”) and are taking medicines
that slow down the normal activity of the brain (“depressants”).
 You have or have had a condition where you can’t completely empty your bladder
(urinary retention), have an enlarged prostate, a blockage in your intestines, or
increased pressure inside your eye. These conditions are sometimes caused by
medicines (called “anti-cholinergics”) that affect the way nerve cells function in
order to treat certain medical conditions.
Tell your doctor immediately if you experience any of the following after taking
Seroquel XL:
 A combination of fever, severe muscle stiffness, sweating or a lowered level of
consciousness (a disorder called “neuroleptic malignant syndrome”). Immediate
medical treatment may be needed.
 Uncontrollable movements, mainly of your face or tongue.
 Dizziness or a severe sense of feeling sleepy. This could increase the risk of
accidental injury (fall) in elderly patients.
 Fits (seizures).
 A long-lasting and painful erection (Priapism).
These conditions can be caused by this type of medicine.
Tell your doctor as soon as possible if you have:
 A fever, flu-like symptoms, sore throat, or any other infection, as this could be a
result of a very low white blood cell count, which may require Seroquel XL to be
stopped and/or treatement to be given.
 Constipation along with persistent abdominal pain, or constipation which has not
responded to treatment, as this may lead to a more serious blockage of the bowel.

Thoughts of suicide and worsening of your depression
If you are depressed you may sometimes have thoughts of harming or killing yourself.
These may be increased when first starting treatment, since these medicines all take
time to work, usually about two weeks but sometimes longer. These thoughts may
also be increased if you suddenly stop taking your medication. You may be more likely
to think like this if you are a young adult. Information from clinical trials has shown an
increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less
than 25 years with depression.
If you have thoughts of harming or killing yourself at any time, contact your doctor or
go to a hospital straight away. You may find it helpful to tell a relative or close friend
that you are depressed, and ask them to read this leaflet. You might ask them to tell
you if they think your depression is getting worse, or if they are worried about changes
in your behaviour.
Weight gain
Weight gain has been seen in patients taking Seroquel XL. You and your doctor
should check your weight regularly.
Children and Adolesecents
Seroquel XL is not for use in children and adolescents below 18 years of age.
Other medicines and Seroquel XL
Tell your doctor if you are taking or have recently taken any other medicines.
Do not take Seroquel XL if you are taking any of the following medicines:
 Some medicines for HIV.
 Azole medicines (for fungal infections).
 Erythromycin or clarithromycin (for infections).
 Nefazodone (for depression).
Tell your doctor if you are taking any of the following medicines:
 Epilepsy medicines (like phenytoin or carbamazepine).
 High blood pressure medicines.
 Barbiturates (for difficulty sleeping).
 Thioridazine or Lithium (other anti-psychotic medicines).
 Medicines that have an impact on the way your heart beats, for example, drugs
that can cause an imbalance in electrolytes (low levels of potassium or
magnesium) such as diuretics (water pills) or certain antibiotics (drugs to treat
infections).
 Medicines that can cause constipation.
 Medicines (called “anti-cholinergics”) that affect the way nerve cells function in
order to treat certain medical conditions.
Before you stop taking any of your medicines, please talk to your doctor first.
Seroquel XL with food, drink and alcohol
 Seroquel XL can be affected by food and you should therefore take your tablets at
least one hour before a meal or prior to bedtime.
 Be careful how much alcohol you drink. This is because the combined effect of
Seroquel XL and alcohol can make you sleepy.
 Do not drink grapefruit juice while you are taking Seroquel XL. It can affect the way
the medicine works.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a
baby ask your doctor for advice before taking Seroquel XL. You should not take
Seroquel XL during pregnancy unless this has been discussed with your doctor.
Seroquel should not be taken if you are breast-feeding.
The following symptoms which can represent withdrawal may occur in newborn babies
of mothers that have used Seroquel in the last trimester (last three months of their
pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation,
breathing problems, and difficulty in feeding. If your baby develops any of these
symptoms you may need to contact your doctor.
Driving and using machines
Your tablets may make you feel sleepy. Do not drive or use any tools or machines until
you know how the tablets affect you.
Seroquel XL contains lactose
Seroquel XL contains lactose which is a type of sugar. If you have been told by your
doctor that you have an intolerance to some sugars, talk to your doctor before taking
this medicine.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking Seroquel XL may cause positive results
for methadone or certain drugs for depression called tricyclic antidepressants (TCAs)
when some test methods are used, even though you may not be taking methadone or
TCAs. If this happens, a more specific test can be performed.
3. How to take Seroquel XL
Always take Seroquel XL exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure. Your doctor will decide on your starting dose.
The maintenance dose (daily dose) will depend on your illness and needs but usually
between 150 mg and 800 mg.
 You will take your tablets once a day.
 Do not split, chew or crush the tablets.
 Swallow your tablets whole with a drink of water.
 Take your tablets without food (at least one hour before a meal or at bedtime, your
doctor will tell you when).
 Do not drink grapefruit juice while you are taking Seroquel XL. It can affect the way
the medicine works.
 Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Liver problems
If you have liver problems your doctor may change your dose.
Elderly people
If you are elderly your doctor may change your dose.
Use in children and adolescents
Seroquel XL should not be used by children and adolescents aged under 18 years.
If you take more Seroquel XL than you should
If you take more Seroquel XL than prescribed by your doctor, you may feel sleepy, feel
dizzy and experience abnormal heart beats. Contact your doctor or nearest hospital
straight away. Take the Seroquel XL tablets with you.
If you forget to take a dose of Seroquel XL
If you forget to take a dose, take it as soon as you remember. If it is almost time to
take the next dose, wait until then. Do not take a double dose to make up for a
forgotten tablet.

If you stop taking Seroquel XL
If you suddenly stop taking Seroquel XL, you may be unable to sleep (insomnia), or
you may feel sick (nausea), or you may experience headache, diarrhoea, being sick
(vomiting), dizziness or irritability. Your doctor may suggest you reduce the dose
gradually before stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Seroquel XL can cause side effects, although not everybody gets
them.
Very common side effects (may affect more than 1 in 10 people):
 Dizziness (may lead to falls), headache, dry mouth.
 Feeling sleepy (this may go away with time, as you keep taking Seroquel) (may
lead to falls).
 Discontinuation symptoms (symptoms which occur when you stop taking Seroquel)
include not being able to sleep (insomnia), feeling sick (nausea), headache,
diarrhoea, being sick (vomiting), dizziness and irritability. Gradual withdrawal over
a period of at least 1 to 2 weeks is advisable.
 Putting on weight.
 Abnormal muscle movements. These include difficulty starting muscle movements,
shaking, feeling restless or muscle stiffness without pain.
 Changes in the amount of certain fats (trigylcerides and total cholesterol).
Common side effects (may affect up to 1 in 10 people):
 Rapid heartbeat.
 Feeling like your heart is pounding, racing or has skipped beats.
 Constipation, upset stomach (indigestion).
 Feeling weak.
 Swelling of arms or legs.
 Low blood pressure when standing up. This may make you feel dizzy or faint (may
lead to falls).
 Increased levels of sugar in the blood.
 Blurred vision.
 Abnormal dreams and nightmares.
 Feeling more hungry.
 Feeling irritated.
 Disturbance in speech and language.
 Thoughts of suicide and worsening of your depression.
 Shortness of breath.
 Vomiting (mainly in the elderly).
 Fever.
 Changes in the amount of thyroid hormones in your blood.
 Decreases in the number of certain types of blood cells.
 Increases in the amount of liver enzymes measured in the blood.
 Increases in the amount of the hormone prolactin in the blood. Increases in the
hormone prolactin could in rare cases lead to the following:
− men and women to have swelling of breasts and unexpectedly produce breast
milk.
− women to have no monthly period or irregular periods.
Uncommon side effects (may affect up to 1 in 100 people):
 Fits or seizures
 Allergic reactions that may include raised lumps (weals), swelling of the skin and
swelling around the mouth.
 Unpleasant sensation in the legs (also called restless legs syndrome).
 Difficulty swallowing
 Uncontrollable movements, mainly of your face or tongue.
 Sexual dysfunction.
 Diabetes.
 Change in electrical activity of the heart seen on ECG (QT prolongation).
 A slower than normal heart rate which may occur when starting treatment and
which may be associated with low blood pressure and fainting.
 Difficulty in passing urine.
 Fainting (may lead to falls).
 Stuffy nose.
 Decrease in the amount of red blood cells.
 Decrease in the amount of sodium in the blood.
 Worsening of pre-existing diabetes.
Rare side effects (may affect up to 1 in 1,000 people):
 A combination of high temperature (fever), sweating, stiff muscles, feeling very
drowsy or faint (a disorder called “neuroleptic malignant syndrome”).
 Yellowing of the skin and eyes (jaundice).
 Inflammation of the liver (hepatitis).
 A long-lasting and painful erection (priapism).
 Swelling of breasts and unexpected production of breast milk (galactorrhoea).
 Menstrual disorder.
 Blood clots in the veins especially in the legs (symptoms include swelling, pain and
redness in the leg), which may travel through blood vessels to the lungs causing
chest pain and difficulty in breathing. If you notice any of these symptoms seek
medical advice immediately.
 Walking, talking, eating or other activities while you are asleep.
 Body temperature decreased (hypothermia).
 Inflammation of the pancreas.
 A condition (called “metabolic syndrome”) where you may have a combination of 3
or more of the following: an increase in the fat around your abdomen, a decrease
in “good cholesterol” (HDL-C), an increase in a type of fat in your blood called
trigylcerides, high blood pressure and an increase in your blood sugar.
 Combination of fever, flu-like symptoms, sore throat, or any other infection with
very low white blood cell count, a condition called agranulocytosis.
 Bowel obstruction.
 Increased blood creatine phosphokinase (a substance from muscles).
Very rare side effects (may affect up to 1 in 10,000 people):
 Severe rash, blisters, or red patches on the skin.
 A severe reaction (called anaphylaxis) which may cause difficulty in breathing or
shock.
 Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
 A serious blistering condition of the skin, mouth, eyes and genitals (StevensJohnson syndrome).
 Inappropriate secretion of a hormone that controls urine volume.
 Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).
Not known (frequency cannot be estimated from the available data):
 Skin rash with irregular red spots (erythema multiforme).



Serious, sudden allergic reaction with symptoms such as fever and blisters on the
skin and peeling of the skin (toxic epidermal necrolysis).
 Symptoms of withdrawal may occur in newborn babies of mothers that have used
Seroquel XL during their pregnancy.
The class of medicines to which Seroquel XL belongs can cause heart rhythm
problems, which can be serious and in severe cases fatal.
Some side effects are only seen when a blood test is taken. These include changes in
the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood,
changes in the amount of thyroid hormones in your blood, increased liver enzymes,
decreases in the number of certain types of blood cells, decrease in the amount of red
blood cells, increased blood creatine phosphokinase (a substance in the muscles),
decrease in the amount of sodium in the blood, and increases in the amount of the
hormone prolactin in the blood. Increases in the hormone prolactin could in rare cases
lead to the following:
 Men and women to have swelling of breasts and unexpectedly produce breast
milk.
 Women to have no monthly period or irregular periods.
Your doctor may ask you to have blood tests from time to time.
Side effects in children and adolescents
The same side effects that may occur in adults may also occur in children and
adolescents.
The following side effects have been seen more often in children and adolescents or
have not been seen in adults:
Very Common side effects (may affect more than 1 in 10 people):
 Increase in the amount of a hormone called prolactin, in the blood. Increases in the
hormone prolactin could in rare cases lead to the following:
− boys and girls to have swelling of breasts and unexpectedly produce breast milk
− girls to have no monthly period or irregular periods.
 Increased appetite.
 Vomiting.
 Abnormal muscle movements. These include difficulty starting muscle movements,
shaking, feeling restless or muscle stiffness without pain.
 Increase in blood pressure.
Common side effects (may affect up to 1 in 10 people):
 Feeling weak, fainting (may lead to falls).
 Stuffy nose.
 Feeling irritated.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting
side effects you can help provide more information on the safety of this medicine.
5. How to store Seroquel XL






Do not store above 30°C. Store in the original package.
Keep out of the sight and reach of children.
Do not use Seroquel XL after the expiry date which is stated on the package. The
expiry date refers to the last day of that month.
Do not throw away medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help to protect the environment.
If the tablets become discoloured or show any other signs of deterioration, you
should seek the advice of your pharmacist.

6. Contents of the pack and other information
What Seroquel XL contains
 Each 50 mg prolonged release tablet contains 50 mg quetiapine (as quetiapine
fumarate).
 Each 200 mg prolonged release tablet contains 200 mg quetiapine (as quetiapine
fumarate).
 Each 300 mg prolonged release tablet contains 300 mg quetiapine (as quetiapine
fumarate).
 Each 400 mg prolonged release tablet contains 400 mg quetiapine (as quetiapine
fumarate).
 The other ingredients are microcrystalline cellulose, sodium citrate, lactose
monohydrate, magnesium stearate, hypromellose, macrogol and titanium dioxide
(E171).
The 50mg, 200mg and 300mg tablets contains yellow iron oxide (E172).
The 50mg tablets also contains red iron oxide (E172).
What Seroquel XL looks like and contents of the pack
Seroquel XL 50mg tablets are peach, bi-convex prolonged release, capsule shaped,
film-coated tablets, marked with XR 50 on one side and plain on the reverse side.
Seroquel XL 200mg tablets are yellow, bi-convex prolonged release, capsule shaped,
film-coated tablets, marked with XR 200 on one side and plain on the reverse side.
Seroquel XL 300mg tablets are pale yellow, bi-convex prolonged release, capsule
shaped, film-coated tablets marked with XR 300 on one side and plain on the reverse
side.
Seroquel XL 400mg tablets are white, bi-convex prolonged release, capsule shaped,
film-coated tablets marked with XR 400 on one side and plain on the reverse side.
Seroquel XL tablets are available in blister packs of 30 or 60.
POM
PL 15814/0938, 15814/0943 Seroquel XL 50mg prolonged release Tablets
PL 15814/0939, 15814/0944, 15814/0962 Seroquel XL 200mg prolonged release Tablets
PL 15814/0940, 15814/0945, 15814/0963 Seroquel XL 300mg prolonged release Tablets
PL 15814/0941, 15814/0946, 15814/0964 Seroquel XL 400mg prolonged release Tablets
The tablets are manufactured by AstraZeneca UK Ltd, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, United Kingdom and is procured from within the
EU and repackaged by the Product Licence Holder OPD Laboratories Limited, Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Seroquel XL is a trade mark of the AstraZeneca group of companies.
Leaflet revision and issue date (Ref) 19.01.2016.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
You can also get information on mental health from the following national
organisations:
 MIND (National Association for Mental Health): Mindinfoline: 0845 7660163
 RETHINK (Formerly the National Schizophrenia Fellowship) Advice Service: 0208
9746814
 National Schizophrenia Fellowship (Scotland): 0131 662 4359
 SANELINE Helpline: 0845 7678000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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